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The PASSmed which includes the subject components, is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The PASSmed Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and titanium unalloyed (T40) that conforms to ASTM F67.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PASSmed Spinal System:

Based on the provided text, the acceptance criteria and study information are quite limited, typical for a Special 510(k) submission which focuses on modifications to an already cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the context of a clinical study with patients or specific data. Instead, it refers to mechanical testing.

• Sample Size: Not specified for the mechanical tests, beyond the implication that "additional components" were tested.
• Data Provenance: The tests were performed in accordance with ASTM F1717 or ASTM F1798, which are standardized mechanical testing methods for spinal implant systems. This implies lab-based mechanical testing, not human or animal data. There is no information on country of origin of the data as it pertains to clinical data, as no clinical data is presented.
• Retrospective/Prospective: Not applicable, as no clinical data is referenced.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" here is mechanical soundness, established by specified ASTM standards, not by expert medical opinion on clinical data.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical "test set" requiring adjudication. Mechanical testing against a standard does not involve adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a medical device (spinal implant) that undergoes mechanical testing and relies on substantial equivalence to predicate devices, not a diagnostic AI system requiring an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used is the mechanical performance standards outlined in ASTM F1717 or ASTM F1798. These standards define the acceptable mechanical properties for spinal implant systems.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI algorithm.

Summary of the Study:

The "study" described is a series of mechanical performance tests conducted on the additional components of the PASSmed Spinal System (specifically the Ø6mm rod and connectors). These tests were performed in accordance with established ASTM (American Society for Testing and Materials) standards: ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) or ASTM F1798 (Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants).

The purpose of these tests was to demonstrate the mechanical equivalence of the modified components to the previously cleared PASSmed devices. The reported outcome states that these tests indicate that the products are as mechanically sound as other PASSmed devices commercially available. This serves as the evidence for meeting the acceptance criteria of mechanical soundness. The reliance on these standardized tests and the comparison to predicate devices is a typical approach for Special 510(k) submissions where the changes are limited and primarily mechanical.

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The PASSmed which includes the subject components, is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The PASSmed Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

The purpose of this submission is to include the following components to PASSmed Spinal System:

• Ø7.2 mm Sacral screw length 30 mm: extension of the range cleared in -K032094
• Ø6.5 mm Sacral screws in lengths ranging from 30 mm to 60 mm: same . design as sacral screws cleared in K032094
• . Ø6 mm pre bent rods in lengths ranging from 40 mm to 110 mm: same design as rods cleared in K032094 before bending
• . Creation of a commercial reference for the nut of polyaxial pedicle screw cleared in K032094.
• Crosslink systems in lengths ranging from 22 mm to 62 mm; the crosslink is a nuts, plate and clamps assembly, that hooks onto the rods to the assembled PASS Spinal System (K032094) to provide torsional stability to the construct.

The provided text describes a Special 510(k) submission (K070276) for the PASSmed Spinal System, focusing on product range extension and additional components. This submission is for a medical device (spinal fixation system), not an AI or software-based device. Therefore, the typical acceptance criteria and study designs associated with AI performance evaluations (like sensitivity/specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.

The "acceptance criteria" for this type of medical device submission are primarily related to mechanical performance and substantial equivalence to a predicate device. The study described is a mechanical performance study.

Here's an analysis based on the provided text, structured to answer the questions as best as possible within the context of a mechanical device:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of components tested. Mechanical testing typically involves a sufficient number of samples to ensure statistical validity, but the specific quantity is not reported in this summary.
• Data Provenance: The tests were performed on "additional components" of the PASSmed Spinal System. The location of the testing is not specified, but the submitter is "MEDICREA® Technologies" based in La Rochelle, France. The tests were likely conducted in a laboratory setting. This is a prospective evaluation of the new components' mechanical properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not Applicable. For mechanical performance studies, "ground truth" is established by adherence to recognized industry standards (like ASTM F1717 or ASTM F1798) and material specifications (ASTM F136). The "ground truth" is the objective mechanical properties as measured against these standards, not expert interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical tests are objective and typically do not require adjudication by multiple human experts. The results are quantitative measurements interpreted against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not Applicable. This is a mechanical device, not an AI or diagnostic software. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. As this is a mechanical medical device, there is no "algorithm" or standalone software performance to evaluate.

7. The Type of Ground Truth Used

• Standardized Mechanical Test Results / Material Specifications: The "ground truth" relies on the objective measurements obtained from tests conforming to ASTM F1717 or ASTM F1798 for mechanical performance, and adherence to ASTM F136 for material composition.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence. The predicate device (K032094) serves as a baseline for comparison.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not applicable. The performance of the predicate device (K032094) was established through similar mechanical testing and regulatory clearance processes.

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The PASSmed is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system PASSmed is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

It also includes hooks and a sacral plate indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The PASSmed system includes pedicies include polyasial screws in a various lengths and diameters. Standard and offist height seres are available, with the offset used in cases of severe spondylolisticsis. Standard and realignment clamps are used to connect the screw and rods. Rods are Ø6mm in lengths ranging from 50mm. It also includes sacral plates and serens. The sacral plate takes the place of pedicle screw in connecting the rod to the sacrum. The place is attached to the sarum with two serews. The polyasial attachment mechanism to the same as the pedicle screws. The plates come in right and left configuration. The rod-plates are similar to the consist of a short rod segment that has enarged portions at the ends with holes to attach directly to screw with hemispherical nuts rather than connecting to the rod was a clamp. The rods attach to the hooks and can be used for single or multiple level lisations. They have the same rod attachment mechanism as the polyasial serews. The laminar hooks are inserted inferior around the lamina, pediele hooks are inserted inferior and superior around the pedicles.

This is a 510(k) summary for a spinal fixation device, not a diagnostic or AI-driven device. As such, the information typically found in acceptance criteria and efficacy studies for software-driven medical devices (such as sensitivity, specificity, reader studies, ground truth establishment) is not applicable here.

The provided document describes the PASSmed Spinal System, a hardware device used for spinal immobilization and stabilization. The "study" mentioned in the document is a non-clinical mechanical test to demonstrate the device's physical properties, not a clinical study involving human patients or a software algorithm evaluating medical images.

Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" in the context of a mechanical spinal implant:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for the ASTM F1717 testing. For mechanical tests of components, this would typically involve a statistically significant number of samples of each device configuration or critical component.
• Data Provenance: The testing was "performed according to ASTM F1717," indicating it was likely conducted in a controlled laboratory setting. No country of origin for data is specified, but the submitter (Medicrea) is from FRANCE, and the contact person is in the USA. Given it's a mechanical test, the origin of the data isn't tied to patient demographics or retrospective/prospective collection as it would be for a clinical diagnostic study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. For a mechanical device, "ground truth" typically refers to the physical properties of the materials and design, evaluated against established engineering standards (like ASTM F1717). There aren't "experts" in the same way as radiologists for image interpretation; rather, there are engineers and technicians who conduct and analyze the mechanical tests according to predefined protocols.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical testing against an ASTM standard doesn't involve "adjudication" in the sense of resolving disagreements among human reviewers. The results are quantitative and objective measurements of material properties and structural integrity.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human readers interpret data. It is not applicable to a mechanical implant device.

6. If a Standalone Performance (i.e. algorithm only without human-in-the-loop performance) was done

• No. This refers to the standalone performance of a software algorithm. The PASSmed Spinal System is a physical implant, not a software algorithm. The "standalone performance" equivalent would be the mechanical performance of the device itself, which was evaluated via ASTM F1717.

7. The Type of Ground Truth Used

• Engineering Standards and Material Specifications. The "ground truth" for a mechanical device is its ability to withstand specified loads, fatigue, and other physical stresses as defined by relevant engineering standards (in this case, ASTM F1717) and the material properties of its components.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. There is no "training set" for this type of device.

Summary of the "Study" Mentioned:

The "study" referenced in the 510(k) summary is identified as:

• "Testing performed according to ASTM F1717."

ASTM F1717 is a standard test method for "Spinal Implant Constructs in a Vertebrectomy Model (Mechanical Testing of Spinal Implants)." This standard specifies the methodology for mechanical characterization of spinal implant assemblies, including pedicle screw systems, under various loading conditions (e.g., static, fatigue).

The purpose of this testing is to demonstrate the mechanical equivalence and safety of the PASSmed system compared to legally marketed predicate devices. The acceptance criterion is that the device is "as mechanically sound as other devices commercially available," which is demonstrated by meeting or exceeding the mechanical performance benchmarks set by the ASTM F1717 standard and comparing favorably to predicate devices that have also undergone similar testing. This is a common approach for demonstrating substantial equivalence for hardware medical devices in 510(k) submissions.

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